Use of PRP from umbilical cord in post-extractive sites

Use of PRP from umbilical cord in post-extractive sites - CH-MAX-FACC-TR-12

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000024-34-IT

Enrollment

Registered

2014-06-06

Start date

2015-01-13

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

• Patients who require extraction of dental elements and subsequent implant rehabilitation in the same site. MedDRA version: 17.0 Level: PT Classification code 10068975 Term: Bone atrophy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Plasma Reach Platelet gel Product Code: Plasma Reach Platelet gel Pharmaceutical Form: Gel INN or Proposed INN: Platelet Reach Plasma gel Other descriptive name: PLATELET CONCENTRATE Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients who require extraction of dental elements and subsequent implant rehabilitation in the same site. • Men and Women • Patients aged between 18 and 75 years old at the time of the surgery • Patients that had signed the Informed Consensus Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Patients with serious clinical situation that, at the researcher’s opinion , advise against the participation at this study. • Patients that take or took medicines that can affect osseous metabolism, and the tissue regeneration and reparation. • Patients that take other sperimental medicines • Patients with uncontrolled diabetes mellitus or serious methabolic diseases • Pregnancy • Patients with neoplastic diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: ?The evaluation of the healing of post-extraction site following administration of PRP obtained from umbilical cord with modulation of specific cytokines;Secondary Objective: ?Analysis of the cell population involved in the healing process ? Assessment of bone resorption around dental implants ;Primary end point(s): ?The evaluation of the healing of post-extraction site following administration of PRP obtained from umbilical cord with modulation of specific cytokines;Timepoint(s) of evaluation of this end point: 2 months	—

Measure

Time frame

Main Objective: ?The evaluation of the healing of post-extraction site following administration of PRP obtained from umbilical cord with modulation of specific cytokines;Secondary Objective: ?Analysis of the cell population involved in the healing process ? Assessment of bone resorption around dental implants ;Primary end point(s): ?The evaluation of the healing of post-extraction site following administration of PRP obtained from umbilical cord with modulation of specific cytokines;Timepoint(s) of evaluation of this end point: 2 months

—

Secondary

Measure	Time frame
Secondary end point(s): Analysis of the cell population involved in the healing process Assessment of bone resorption around dental implants ;Timepoint(s) of evaluation of this end point: 2 months for Analysis of the cell population involved in the healing process 16 months for Assessment of bone resorption around dental implants	—

Countries

Italy

Contacts

Public ContactChirurg.Maxillo-Facc(C.Marchetti)

AOU di Bologna, Policlinico S.Orsola-Malpighi

claudio.marchetti@unibo.it00390516364205

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026